MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Failure to Auto Stop (2938)

Patient Problem Tissue Damage (2104)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that on (b)(6) 2019, a codman disposable perforator malfunctioned and caused injury to the patient¿s brain.The contaminated perforator was saved and is in a biohazard bag.Two other perforators were opened (both with different lot numbers), were deemed to be unsatisfactory and were not used on patient.The products will be returned for evaluation.Additional information received on (b)(6) 2019 indicated that the one listed as lot unknown was used on a patient.The perforator ¿plunged¿ through the dura but did not damage the brain tissue it did ¿score¿ the dura.The perforator became stuck to the point that the drill had to be disconnected from the perforator and a ¿flap¿ turned with the midas craniatome.The bone flap removed was then removed from the patient¿s head and the perforator ¿pried¿ out of the bone.The other 2 perforators were opened and ¿tested¿ to see the clutch was functioning and both were noted not to depress and ¿lock¿ as they are expected to so they were not used on the patient.No delay in the procedure were noted.

Manufacturer Narrative

The perforator was received for evaluation.Dhr - there is no indicated that the production process may have contributed to this complaint.All test results passed procedural specifications.Udi # (b)(4), lot j1041k, manufactured on 02oct2018 and expires on 30sep2023, from the perforator product family failure analysis - the perforator unit was visually inspected using the unaided eye and organic matter, damaged sleeve, and missing label was observed.The returned unit was found to meet all acceptance criteria.The complaint could not be verified through failure analysis.The cause cannot be confirmed, as no issues relevant to the failure were noted from the dhr review, trending, or failure analysis, and proper finished goods testing was performed prior to release.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr (b)(4) and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6), director of regulatory programs, office of product evaluation and quality and (b)(6), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8817456
• MDR Text Key: 151928310
• Report Number: 1226348-2019-00282
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 261221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1